Identity
- Trade Name
- SheathLessPV, 6 Fr, Angle45, 120cm EUDAMED
- Device Name
- SheathLessPV Peri-Vascular Guiding System EUDAMED
- Model / Reference
- W8AN45-0-V120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327083249 EUDAMED
- Basic UDI-DI
- B-04547327083249 EUDAMED
- EMDN Code
- C0104020204 PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
SheathLessPV, 6 Fr, Angle45, 120cm by Asahi Intecc Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04547327083249 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
- EUDAMED SRN
- JP-MF-000010199
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 1d145b94-7f45-47a0-8a55-bd7d0939f1c8 61 fields · synced Jun 19, 2026